The Impact of Germanium-Embedded Knee Brace on Patient Recovery After Knee Arthroscopy

NCT05090670 | Unknown

• 1 other identifier: IW002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anti-inflammatory brace technology has demonstrated superior clinical outcomes in the management of knee osteoarthritis and accelerate recovery time for Major League Soccer players. Authors have postulated that embedding germanium into cotton garments increases circulation and augments the inflammatory process through a transdermal micro-electromagnetic field. In addition to immunomodulatory effects, knee braces immobilize and stabilize the joint through tactile feedback from the skin. Thus, a germanium-embedded knee brace may provide inflammatory control to augment pain and edema while concomitantly enhancing proprioception. Knee Arthroscopy rehabilitation goals during the acute post-operative phase include diminishment of pain and edema as well as restoration of knee range-of-motion. The presented study intends to assess the impact of a germanium-embedded knee brace on patient recovery after Knee Arthroscopy. Single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing Knee Arthroscopy. Patients will be randomized into germanium-infused knee brace group and compared to a replica knee brace group. Inclusion criteria will include skeletally mature individuals undergoing primary Knee Arthroscopy. Exclusion criteria will include autoimmune disorders and history of surgery on ipsilateral joint. The presented protocol intends to assess the impact of a germanium-embedded knee brace on patient recovery after Knee Arthroscopy. The primary outcome measure was chosen for its implications for the design and conduct of the study,1 including well-validated outcome instrument for comparison, facilitation of a priori power analysis, randomization, and blinding. Secondary outcomes were chosen for their pertinence to surgeon decision-making during patient rehabilitation.

Conditions

Knee Arthroscopy; Knee Arthropathy Associated With Other Conditions

Outcome Measures

Primary Outcomes (1)

• Short Form 36 (SF-36)

  A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.

  4 weeks

Secondary Outcomes (3)

• Pain Estimation

  6 weeks

• Leg Circumference

  6 weeks

• Knee Range of Motion

  6 weeks

Study Arms (2)

Germanium-Embedded Knee Brace

EXPERIMENTAL

Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace

Other: Incrediwear Germanium-Embedded Knee Brace following Knee Arthroscopy

Replica Knee Brace

ACTIVE COMPARATOR

Following surgery the patients effected limb would be placed in a replica knee brace

Other: Replica Knee Brace

Interventions

Incrediwear Germanium-Embedded Knee Brace following Knee Arthroscopy OTHER

Germanium-Embedded Knee Brace will be applied to the effected limb following Knee Arthroscopy

Germanium-Embedded Knee Brace

Replica Knee Brace OTHER

Replica Knee brace will be applied to the effected limb following Knee Arthroscopy

Replica Knee Brace

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Male or female
• Compliant patient
• BMI less than 35
• Undergoing Knee Arthroscopy within 30 days

You may not qualify if:

• Rheumatoid Arthritis
• Poorly controlled diabetes (HgA1c \> 7.5)
• Previous blood clots
• BMI greater than 35
• Varicosities on operative leg

Sponsors & Collaborators

• Total Sports Medicine & Orthopedics: lead
• INCREDIWEAR HOLDINGS, INC.: collaborator

Central Study Contacts

Shanthan C Challa, MD

CONTACT

7024998579; shanthancchalla@gmail.com

Roddy McGee

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 25, 2021
• Study Start: November 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share